MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON CLOSURE SYSTEM (ACS), NYLON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number 8065698001

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Conjunctivitis (1784); Hyperemia (1904)

Event Date 11/26/2022

Event Type  Injury  

Event Description

A government agency reported that during the cataract operation, the incision needed to be sutured with a non-absorbable surgical suture.Twelve hours after the operation, conjunctiva became congested and conjunctival hyperemia developed.Antibiotic eyedrops were immediately given.After five hours of medication, the discomfort gradually disappeared.

Manufacturer Narrative

Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

A sample was not received at the manufacturing site for evaluation for the report of conjunctivitis and hyperemia; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number, indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Because a sample was not received and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.The exact root cause for this complaint is unknown, therefore, specific action with regards to this complaint cannot be taken.Suture material samples are tested at incoming for tensile strength and diameter and visually inspected for any defects such as discoloration and frays.Sutures are also 100% inspected by trained operators for discoloration and frays and for proper attachment during the manufacturing process.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON CLOSURE SYSTEM (ACS), NYLON
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 16185479
• MDR Text Key: 307496337
• Report Number: 2523835-2023-00028
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 00380656980018
• UDI-Public: 00380656980018
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K930517
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8065698001
• Device Lot Number: 312472M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 64 YR
• Patient Sex: Female